Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)

Condition(s) studied

Investigational drug(s) / intervention(s)

Cognitive-behavioral therapy: The mobile application will include the following modules: 1. Psychoeducation: information about what to expect from each phase of the surgical process (i.e., pre-operative, the surgery itself and the post-operative). 2. Activation control techniques: to teach different activation control techniques such as relaxation, breathing techniques and mindfulness training. 3. Cognitive restructuring and problem solving: to teach how to change maladaptive pain-related beliefs for more adaptive ones and how to better cope with pain. 4. Exercises and tasks: to encourage the use of the learning strategies we will offer a number of exercises and tasks 5. Parent's module: to teach parents about the surgical process and how they can help their children during the process

Study summary

Chronic postsurgical pain is a health problem with a great societal impact: approximately 20% of all children and adolescents undergoing surgery will develop chronic pain. Importantly, the risk and protective factors that are known (e.g., anxiety, catastrophizing, pain beliefs and pain coping) are modifiable, thus there is a huge potential for the development of both preventive and protective programs to avoid the transition from acute to chronic pain or reduce the impact in the lives of patients when it has already developed.

Eligibility

Primary outcome measure(s)

• Pain intensity (pre and postsurgical) — Baseline (pre); daily for 15 days post-surgery; at 3 and 6 months follow-up
  Pain intensity will be recorded using the 0-10 Numerical Rating Scale, with higher scores indicating greater pain intensity
• Pain interference (pre and postsurgical) — Baseline (pre), and at 3 and 6 months after surgery (post)
  Pain intensity will be recorded using the 8-item PROMIS Pediatric Pain Interference Scale, with higher scores indicating greater pain interference. PROMIS measures are scored as T-scores, with a mean of 50 points and an SD of 10.

Trial sites (3)

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